Why it was recalled
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Product description
Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10
Lot numbers, UPCs & expiration codes
Lot #BPA801A, EXP 12/2020
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1851-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 21, 2019
- FDA report date
- Sep 18, 2019
- Quantity
- 1837 90-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharma Usa Inc
Original FDA data
Every field from FDA enforcement report D-1851-2019, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83597
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230
- Code information
- Lot #BPA801A, EXP 12/2020
- Postal code
- 08536-0009
- Report date
- Sep 18, 2019
- Product type
- Drugs
- Recall number
- D-1851-2019
- Classification
- Class III
- Recalling firm
- Macleods Pharma Usa Inc
- Product quantity
- 1837 90-count bottles
- Termination date
- Jan 28, 2021
- Reason for recall
- Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Aug 21, 2019
- Initial firm notification
- Letter
- Center classification date
- Sep 11, 2019